Effects of Exercise Training on Exercise Capacity and Sleep Quality in Patients With Obesity Hypoventilation Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Six Minutes Walk Test
研究概览
简要总结
Obesity Hypoventilation Syndrome is defined as a combination of obesity (BMI ≥ 30 kg/m2) and daytime hypercapnia in arterial blood gas analysis (PaCO2 > 45 mmHg) without other pathologies that cause hypoventilation. Symptoms seen in individuals diagnosed with OHS are stated as a feeling of suffocation due to apnea, loud snoring, morning headache and excessive daytime sleepiness. Respiratory mechanics, respiratory muscle performance, pulmonary gas exchange, lung functions and exercise capacity parameters are adversely affected in patients. Early treatment is important so that these negative changes do not lead to worse outcomes. Weight control, bariatric surgery, pharmacological treatment and non-invasive mechanical ventilation (NIMV) are included in the treatment program of OHS patients. The effects of exercise on the treatment program of OHS patients are unknown. Considering all the studies in the literature, the primary purpose of this study is to evaluate aerobic and strength training on exercise capacity and sleep quality in patients with hypoventilation syndrome. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength, emotional state, body composition and quality of life parameters. In addition, the researchers believe that this study will form the basis for further scientific studies on OHS and exercise and will make an important contribution to the literature.
详细描述
Patients with Obesity Hypoventilation Syndrome followed for at least 1 month in the Department of Chest Diseases, Faculty of Medicine, Istanbul University will be included in the study. The patients will be divided into two groups using the computer-assisted randomization program as the study and control groups. The study will be conducted in accordance with the Declaration of Helsinki and consent form will be obtained from the patients participating in the study, indicating that they are willing to participate in the study. Before starting the study, the purpose of the study will be explained to the participants and all information about the study will be given. After 10 weeks of exercise training, patients will be evaluated with, Six-Minute Walking Test, pittsburgh sleep quality index, Body Composition, Nottingham Health Profile, Hospital Anxiety and Depression Scale and Muscle strength. The primary aim is to examine the effects of evaluate aerobic and strengthening training on exercise capacity and sleep quality in patients with hypoventilation syndrome. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength, emotional state, body composition and quality of life parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Patients who have been diagnosed with Obesity Hypoventilation Syndrome
排除标准
- •Patients who participate in any other diet program
- •Patients who are incompatible with a diet program or exercise program
- •Patients with uncontrollable respiratory and comorbid diseases
- •Patient who have been an orthopedic, neurological, cardiac, or metabolic condition that may prevent participation and continuation of the exercise program throughout the study
研究组 & 干预措施
Training (Exercises and Diet) Group
Training (Exercises and Diet) Group; Patients will follow a regular diet program for 10 weeks.
Aerobic exercises will be planned for patients 2 days a week under the supervision of a physiotherapist, and 3 days a week as home exercises.
Strengthening exercises will be planned for patients 1 days a week under the supervision of a physiotherapist, and 2 days a week as home exercises.
干预措施: Exercises and Diet (Other)
Control (Diet) Group
Control (Diet) Group; Patients will follow a regular diet program for 10 weeks.
干预措施: Diet (Other)
结局指标
主要结局
Six Minutes Walk Test
时间窗: 10 weeks
The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes. The distance that normal individuals should take in this period is 400-700 meters. In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing. Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.
Pittsburgh Sleep Quality Index
时间窗: 10 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.
Six Minutes Walk Test
时间窗: 10 weeks
The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes. The distance that normal individuals should take in this period is 400-700 meters. In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing. Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.
Pittsburgh Sleep Quality Index
时间窗: 10 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.
Epworth Sleepiness Scale
时间窗: 10 weeks
The Epworth Sleepiness Scale is designed to assess the tendency to fall asleep during the day and the frequency of such episodes. It consists of eight different situations in which participants rate their likelihood of dozing off. Each item is scored on a 4-point scale ranging from 0 to 3, resulting in a total score between 0 and 24. A total score greater than 10 indicates excessive daytime sleepiness.
次要结局
- Nottingham Health Profile(10 weeks)
- Hospital Anxiety and Depression Scale(10 weeks)
- Muscle Strength - Dynamometer(10 weeks)
- Body Fat Percentage(10 weeks)
- Body Fluid Percentage(10 weeks)
- Muscle Mass(10 weeks)
- Body Mass Index(10 weeks)
- Nottingham Health Profile(10 weeks)
- Hospital Anxiety and Depression Scale(10 weeks)
- Muscle Strength - Dynamometer(10 weeks)
- Body Fat Percentage(10 weeks)
- Body Fluid Percentage(10 weeks)
- Muscle Mass(10 weeks)
- Body Mass Index(10 weeks)
- Handgrip Strength(10 weeks)
- Physical Activity Level(10 weeks)
- Neck Circumference(10 weeks)
- Waist circumference(10 weeks)
- Hip circumference(10 weeks)
研究者
Goksen Kuran Aslan
Associated Proffesor
Istanbul University